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English: Logo of Pfizer Incorporated. (Photo credit: Wikipedia)

Here is a case that has brand-name drugmakers are on edge. Last month, the Alabama Supreme Court issued a highly contentious ruling that Pfizer can be sued by a man who claimed he was injured by a generic version of its Reglan heartburn medicine. Why? The brand-name drugmaker purportedly failed to warn his physician about the risks. Now, Pfizer is asking for a re-hearing to reverse what some say could become a special kind of legal hell for brand-name drugmakers.

The decision is one of the few instances in which a court has found that a brand-name drugmaker can be sued even though a consumer had taken only a generic. And this has incensed not only Pfizer, but the pharmaceutical industry trade group and the US Chamber of Commerce, because the Alabama court decision suggests consumers will be encouraged to file still more such lawsuits in the state, especially in the wake of a 2011 ruling by the US Supreme Court that has limited claims against generic drugmakers.

In that instance, the US Supreme court decided generic drugmakers are not required to strengthen labeling if alerted to side effects, even when the same change has not been made to the labeling for the branded medicines. Under current FDA regulations, generic drugmakers cannot update labeling, even if they become aware of a potential risk not mentioned in the labeling. Brand-name drugmakers, though, can update warnings and precautions on product labeling before obtaining FDA approval. In other words, the generic drugmaker is required only to match its labeling to brand-name labeling.

The US Supreme Court decision means generic drugmakers cannot be sued for not alerting patients to such risks (read more here). Now, though, the Alabama Supreme Court seems to have offered consumers another option. In the Alabama case, a consumer took Reglan and developed tardive dyskinesia, which causes incurable and involuntary muscle movements, and accused Wyeth, which is now owned by Pfizer, of failing to warn of the risk of long-term use. And the state court ruled the lawsuit against Pfizer can be pursued.

The drugmaker insists, however, that the Alabama State Court goofed by allowing the consumer to circumvent state product liability law and, instead, present his claim as fraud and misrepresentation. Pfizer also argues the state court should have noted that, for the consumer to have prevailed, there is a requirement that the drugmaker owed him what is known as a duty of care and disclosure. But Pfizer mainatins this was simply not possible because the consumer took a generic version of Reglan. In effect, there was no means by which to establish a relationship to convey information.

And so, both Pfizer and the Pharmaceutical Research & Manufacturers of America argue that brand-name drugmakers will, effectively, become insurers for the prescription drug market. “If allowed to stand, the court’s decision will radically alter the financial realities of drug innovation, forcing brand-name manufacturers to anticipate that, after their period of exclusivity has expired, they will, nonetheless, be responsible for an ever-growing generic market over which they have no control and from which they derive no profit,” Pfizer writes in its brief.

Pfizer, by the way, faces numerous lawsuits over Reglan and this is not the first time that such a decision has been made over warnings for the medication. In California, an appeals court issued such a finding in late 2008 and a Vermont court also made a similar decision two years. However, Pfizer points out that 61 decisions in 23 states have ruled against claims that tried to hold a brand-name drugmaker responsible for injuries allegedly caused by a generic version of Reglan. In other words, the drugmaker is trying to assert that a consensus view exists and Alabama is an outlier.

Whether the Alabama Supreme Court will agree to a rehearing is unclear. Although it is worth noting that a dissent written by one justice, Judge Glenn Murdock, wss belatedly released. And while he made a point of noting that there is no good outcome in such a case, he expressed concern that the majority opinion created a "precedent that poses a danger for the prescription medicine industry, and by extension, all industry." Indeed, this is why the US Chamber of Commerce filed a friend-of-the-court brief backing Pfizer.

Meanwhile, though, the issue may be decided by the FDA. The agency recently disclosed plans to revise its regulations so that generic drugmakers can update product labeling and warn patients about risks associated with their drugs. If the FDA were to make such a change, generic drugmakers could be sued in state courts - if they become aware of evidence of serious side effects, but do not take action to update the product labeling (back story). But it is also not clear how long the FDA will take to update regulations. Consequently, Pfizer may just have to ask the US Supreme Court for some help.